MA pols wary of new Rx opioid

Most of that was the result of a record number of opioid-related deaths. "Addressing it is a public health priority for the FDA".

Kolodny called Dsuvia an "exceptionally dangerous" drug that is 10 times stronger than fentanyl, which is 50 times stronger than heroin.

Drug overdose deaths hit the highest level ever recorded in the United States past year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001.

"To what extent should we evaluate each opioid exclusively on its own merits, and to what extent should we also consider. the epidemic of opioid misuse and abuse that's gripping our nation?" Clearly, something is in the wrong as the United States drug crisis gets worse with every passing day. "The military application for this new medicine was carefully considered in this case", Dr. Gottlieb said in a statement. That panel recommended the drug's approval despite his warning. The plan would presumably help the agency consider a narcotic's benefit to public health. "To what extent should we evaluate each opioid exclusively on its own merits, and to what extent should we also consider.the epidemic of opioid misuse and abuse that's gripping our nation?" The agency would look into all of these factors before making a decision on approving an opioid or not.

"In this way, [drug companies] would know up front where the opportunities are for developing new drugs that meet the FDA's standards for safety and effectiveness", he wrote.

Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis. Each pill, placed under the tongue for quick absorption, would have the same impact as five milligrams of intravenous morphine. The drug, Dsuvia, is a tablet form of sufentanil, a synthetic opioid that has been used intravenously and in epidurals since the 1980s.

"DSUVIA will not be available in retail pharmacies or for outpatient use".

However, despite the FDA's best wishes and intentions, a lot of people have come forward with criticism. "It will be taken by medical personnel and others for whom it has not been prescribed". The numbers say it all: More people die in the USA each year from drug overdoses than from breast cancer. The guidelines would allow the agency to consider a narcotic's benefit to public health, its risk of being diverted for inappropriate use or abuse and its unique benefits to groups of people in pain before deciding to approve an opioid.

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